Norofas Pour-On Solution for Cattle

Main information

  • Trade name:
  • Norofas Pour-On Solution for Cattle
  • Pharmaceutical form:
  • Pour-on solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Norofas Pour-On Solution for Cattle
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0369/001
  • Authorization date:
  • 10-12-2011
  • EU code:
  • UK/V/0369/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:July2013

AN:00254/2013

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

NorofasPour-OnSolutionforCattle(UK)

ClosamectinPour-OnSolutionforCattle(FR)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveIngredient(s)

Ivermectin 5mg/mL

Closantel(asclosantelsodium) 200mg/mL

Excipients

BrilliantBlueFCF(E133) 0.1mg/mL

Forafulllistofexcipientsseesection6.1.

3. PHARMACEUTICALFORM

Pour-Onsolution.

Aclearblue/greensolution.

4. CLINICALPARTICULARS

4.1 TargetSpecies

Cattle

4.2 IndicationsforUse,SpecifyingtheTargetSpecies

Forthetreatmentofmixedtrematode(fluke)andnematodeor

arthropodinfestationsduetoroundworms,lungworms,eyeworms,

warbles,mitesandliceofcattle.

Gastrointestinalroundworms(adultsandfourthstagelarvae)

Ostertagiaostertagi(includinginhibitedO.ostertagi),Haemonchus

placei,Trichostrongylusaxei,Trichostrongyluscolubriformis,Cooperia

spp,Oesophagostomumradiatum,Nematodirushelvetianus(adult),

Strongyloidespapillosus(adult).

Lungworms(adultandfourthstagelarvae)

Dictyocaulusviviparus

Trematodes(adultandlateimmatures)

Fasciolagigantica

Fasciolahepatica

Treatmentofflukeat12weeks(mature).

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Treatmentofflukeat7weeks(lateimmature).

Eyeworms(adult)

Thelaziaspp

Cattlegrubs(parasiticstages)

Hypodermabovis,Hypodermalineatum

Lice

Linognathusvituli,Haematopinuseurysternus,Damaliniabovis

MangeMites

Chorioptesbovis,Sarcoptesscabieivarbovis

4.3 Contraindications

Donotuseincasesofknownhypersensitivitytotheactivesubstances.

Donotapplytoareasofskinwhichhavemange,scabsorotherlesions

ortoareascontaminatedwithmudormanure.

Avermectinsmaynotbewelltoleratedinnon-targetspecies(casesof

intolerancewithfataloutcomearereportedindogs –especiallyCollies,

OldEnglishSheepdogsandrelatedbreedsorcrosses,andalsoin

turtles/tortoises).

4.4 SpecialWarnings

Careshouldbetakentoavoidthefollowingpracticesbecausethey

increasetheriskofdevelopmentofresistanceandcouldultimately

resultinineffectivetherapy.

Toofrequentandrepeateduseofanthelminticsfromthesameclass,

overanextendedperiodoftime.

Underdosingwhichmaybeduetounderestimationofbodyweight,

misadministrationoftheproduct,orlackofcalibrationofthedosing

device.

Theeffectofrainonthepour-onformulationatthetimeofandafter

applicationhasnotbeeninvestigated.Formaximumeffectanimals

shouldbekeptindoorsorundercoverfollowingtreatment,whenthere

israinoranimminentriskofrain.

Suspectedclinicalcasesofresistancetoanthelminticsshouldbe

furtherinvestigatedusingappropriatetests(e.g.,FaecalEggCount

ReductionTest).Wheretheresultsofthetestsstronglysuggest

resistancetoaparticularanthelmintic,ananthelminticbelongingto

anotherpharmacologicalclassandhavingadifferentmodeofaction

shouldbeused.

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ResistancetoivermectinhasbeenreportedinCooperiasppincattle.

Thereforetheuseofthisproductshouldbebasedonlocal

epidemiologicalinformationaboutthesusceptibilityoftheCooperiaspp

andrecommendationsonhowtolimitfurtherselectionforresistanceto

anthelmintics.

4.5 SpecialPrecautionsforUse

i. Specialprecautionsforuseinanimals

ItisnotadvisabletoadministertheproductwhenHypoderma

lineatumlarvaearelocalisedintheperiaesophagicregion,or

whenHypodermabovislarvaearesituatedinthespinalcanal.

Seekprofessionalveterinaryadvicetodeterminethebestperiod

ofuse.

Careshouldbetakentoensureanimalsarenotoverdosedby

theapplicationvolume,accidentalspillageororalingestion,as

overdosagemayresultinsignsoftoxicitysuchasinco-

ordinationandblindness.Itisrecommendedthatanimalsare

notclippedpriortotreatmenttoreducetheriskofincreased

drugabsorptionandhencebioavailability,ororalingestion

throughmutualgrooming.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Thisproductmaybeirritatingtohumanskinandeyesandusers

shouldbecarefulnottoaccidentallysplashitonthemselvesor

others.Wearnitrilerubberglovesandbootswithawaterproof

coatwhenapplyingtheproduct.Protectiveclothingshouldbe

washedafteruse.Ifaccidentalskincontactoccurs,washthe

affectedareaimmediatelywithsoapandwater.Ifaccidental

eyeexposureoccurs,flushtheeyesimmediatelywithwaterand

getmedicalattention.

Donotsmokeoreatwhilsthandlingtheproduct.Washhands

afteruse.Useonlyinwellventilatedareasoroutdoors.

iii. OtherPrecautions

Theproductisverytoxictoaquaticorganismsanddunginsects.

Treatedcattleshouldnothavedirectaccesstoponds,streams

orditchesfor14daysaftertreatment.

Longtermeffectsondunginsectscausedbycontinuousor

repeatedusecannotbeexcludedthereforerepeattreatmentson

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apasturewithinaseasonshouldonlybegivenontheadviceof

aveterinarian.

4.6 AdverseReactions(FrequencyandSeriousness)

Undesirableeffectsarenotexpectedwhentheproductisusedatthe

recommendeddoserate.

Inveryrarecases,neurologicalsignssuchasblindnesshavebeen

observedafteruseoftheproduct.

4.7 UseDuringPregnancy,LactationorLay

NorofasPour-Oncanbeadministeredtocattle(includingdairy,

beef/sucklercattle)atanystageofpregnancyorlactationprovidedthat

themilkisnotintendedforhumanconsumption.SeeSection4.11.

4.8 InteractionswithOtherMedicinalProductsandOtherFormsof

Interaction

Noneknown.

4.9 AmountstobeAdministeredandAdministrationRoute

Theveterinarymedicinalproductshouldbeadministeredtopicallyata

dosagerateof500

givermectinperkgbodyweightand20mg

closantelperkgbodyweight(1mLper10kg).

Theformulationshouldbeappliedalongthemidlineofthebackina

narrowstripbetweenthewithersandthetailhead.

Assessbodyweightcarefullypriortoadministration.

Thetimingfortreatmentshouldbebasedonepidemiologicalfactors

andshouldbecustomisedforeachindividualfarm.Adosing

programmeshouldbeestablishedbyaveterinaryprofessional.

HANDYDOSINGGUIDE ANIMALSSHOULDBEWEIGHEDAND

GROUPEDACCORDINGTOBODYWEIGHT

TOAVOIDUNDEROROVER-DOSING*

BODYWEIGHT DOSE

VOLUME NUMBEROFFULLDOSESPERPACK

250ml

500ml 1litre 2.5

litre 5litre

100kg* 10ml 25 50 100 250 500

150kg 15ml 16 33 66 166 333

200kg 20ml 12 25 50 125 250

250kg 25ml 10 20 40 100 200

300kg 30ml 8 16 33 83 166

350kg 35ml 7 14 28 71 142

400kg 40ml 6 12 25 62 125

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450kg 45ml 5 11 22 55 111

500kg 50ml 5 10 20 50 100

550kg 55ml 4 9 18 45 90

600kg 60ml 4 8 16 41 83

*Doserate1mlper10kgbodyweight

4.10Overdose(Symptoms,EmergencyProceduresandAntidotes)(if

necessary)

Atdosesofthreetimestherecommendeddose,nosignificantclinical

signswererecorded.

Ivermectin

Noantidotehasbeenidentified.Symptomatictreatmentmaybe

beneficial.

Closantellikeothersalicylanilidesisapotentuncouplerofoxidative

phosphorylationandthesafetyindexisnotashighasisthecaseof

manyotheranthelmintics.Howeverwhereusedasdirectedthereare

unlikelytobeanyuntowardeffects.Signsofoverdosagecaninclude

slightlossofappetite,loosefaeces,decreasedvisionandincreased

frequencyofdefecation.Highdosesmaycauseblindness,

hyperventilation,generalweaknessandinco-ordination,hyperthermia,

convulsions,tachycardiaandinextremecasesdeath.Treatmentof

overdosageissymptomaticasnoantidotehasbeenidentified.

4.11WithdrawalPeriods

Meatandoffal:28days.

Milk:Notauthorisedforuseincattleproducingmilkforhuman

consumptionincludingduringthedryperiod.Donotuseduringthe

secondhalfofpregnancyinheiferswhichareintendedtoproducemilk

forhumanconsumption.

Duetothesignificantlikelihoodofcross-contaminationofnon-treated

animalswiththisproductduetogrooming(licking),allanimalsina

groupshouldbetreatedatthesametimeandtreatedanimalsshould

bekeptseparatelyfromnon-treatedanimalsthroughoutthewithdrawal

period.Non-compliancewiththisrecommendationmayleadto

residuesviolationsinnon-treatedanimals.

5. PHARMACOLOGICALPROPERTIES

ATCVetCode:QP54AA51

PharmacotherapeuticGroup:Ivermectin,combinations.

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5.1 PharmacodynamicProperties

Ivermectinisanendectocidewithactivityagainstawiderangeof

internalandexternalparasites.Ivermectinisamacrocyliclactoneand

actsbyinhibitingnerveimpulses.Itbindsselectivelyandwithhigh

affinitytoglutamate-gatedchlorideionchannelswhichoccurin

invertebratenerveandmusclecells.Thisleadstoanincreaseinthe

permeability of the cell membrane to chloride ions with

hyperpolarizationofthenerveormusclecell,resultinginparalysisand

deathoftherelevantparasites.Compoundsofthisclassmayalso

interactwithotherligand-gatedchloridechannels,suchasthosegated

bytheneurotransmittergamma-aminobutyricacid(GABA).The

marginofsafetyforcompoundsofthisclassisattributabletothefact

thatmammalsdonothaveglutamate-gatedchloridechannels.The

macrocyliclactoneshavealowaffinityforothermammalianligand-

gatedchloridechannelsandtheydonotreadilycrosstheblood-brain

barrier.

Closantelisamemberofthesalicylanilideclassofanthelmintics.

Salicylanilidesarehydrogen(proton)ionophores(referredtoas

oxidativephosphorylaseuncouplers.)

Thechemicalstructureofsalicylanilidesillustratethepossessionofa

detachableproton.Thistypeofmoleculeislipophilicandisknownto

shuttleprotonsacrossmembranes,inparticulartheinnermitochondrial

membrane.Closantelactsbyuncouplingoxidativephosphorylation.

Closantelisaparasiticidewithflukicideactivityandefficacyagainst

certainotherhelminthsandarthropods.

5.2 PharmacokineticProperties

AftertopicaladministrationofNorofasPour-Ontocattleatadoserate

of500µgivermectinperkgand20mgclosantelperkgthefollowing

parameterswereobserved:

Ivermectin –Cmaxof19.13ng/mLandAUCof2440ng.hr/mL

Closantel –Cmaxof68.5µg/mLandAUCof35207µg.hr/mL.

Ivermectin,Tmax=48hours,terminalhalf-life=80.00hours

Closantel,Tmax=120hours,terminalhalf-life=267.55hours

Ivermectinisonlypartiallymetabolised.Incattle,onlyabout1to2%is

excretedintheurinetheremainderisexcretedinthefaeces,

approximately60%ofwhichisexcretedasunaltereddrug.The

remainderisexcretedasmetabolitesordegradationproducts.

Salicylanilidesarepoorlymetabolisedandareexcretedmainly

unchanged.About90%ofclosantelisexcretedunchangedinthe

faecesandurineincattle.

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6. PHARMACEUTICALPARTICULARS

6.1 ListofExcipient(s)

BrilliantBlueFCF(E133)Dye

AnhydrousEthanol

Macrogol

CetearylEthylhexanoate

IsopropylMyristate

Povidone

DenatoniumBenzoate

Trolamine

Isopropylalcohol

6.2 Incompatibilities

Noneknown.

6.3 Shelf-Life

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:18

months.

6.4 SpecialPrecautionsforStorage

Donotstoreabove25°C.

Storeuprightinoriginalcontainer.

Protectfromlight.

Discardunusedmaterial.Avoidintroductionofcontamination.

Replacethecapsecurelyafteruse.

Ifstoredattemperaturesbelow0

C,NorofasPour-OnSolutionfor

Cattlemayappearcloudy.Allowingtowarmatroomtemperaturewill

restorethenormalappearancewithoutaffectingefficacy.

Flammable –keepawayfromheat,sparks,openflameorother

sourcesofignition.

6.5 NatureandCompositionofImmediatePackaging

Translucent250mL,500mLand1LHDPEcontainerswithwhite

HDPEcapsandwhite1L,2.5Land5LHDPEbackpackswithwhite

polypropylenescrewcaps.

Notallpackssizesmaybemarketed.

6.6 SpecialPrecautionsfortheDisposalofUnusedVeterinary

MedicinalProductorWasteMaterialsDerivedfromtheUseof

SuchProducts,ifappropriate

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EXTREMELYDANGEROUSTOFISHANDAQUATICLIFE.Donot

contaminatesurfacewatersorditcheswiththeproductorused

container.Anyunusedveterinarymedicinalproductorwastematerials

derivedfromsuchveterinarymedicinalproductsshouldbedisposedof

inaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

Newry

CoDown

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm :02000/4312

9. DATEOFFIRSTAUTHORISATION

Date:23June2011

10. DATEOFREVISIONOFTHETEXT

Date:July2013

Approved:29/08/2013